Cryosurgery system

ABSTRACT

A cryosurgery system for application of medical-grade liquid nitrogen to a treatment area via a small, low pressure, open tipped catheter. The system includes a console, including a touch panel computer, a cryogen module, a suction module and an electronics module, and a disposable spray kit. Features include optional low cryogen flow setting to reduce the cryogen flow rate by 50%, improved cryogen flow consistency reducing pressure pulses and peaks, an integrated suction pump for improved consistency and self-checks, specified vent tube areas and corresponding maximum expected pressures during cryospray procedure; optional pressure sensing capability to monitor pressure during a treatment, and novel catheter designs of multilayer and flexible construction providing a variety of spray patterns.

BACKGROUND

1. Field of the Invention

The present invention relates generally to cryospray systems, cryogenicspray ablation and cryosurgery systems, and more particularly, to anadvanced cryospray ablation system having consistent cryogen flow andflow control, an integrated suction pump, a body cavity pressure sensorand an assortment of flexible cryogen delivery catheters.

2. Related Art

A variety of medical conditions may be treated by ablation of tissuewithin the body. Tissue ablation refers to the removal or destruction oftissue, or of tissue functions. Traditionally, invasive surgicalprocedures were required to perform tissue ablation. These surgicalprocedures required the cutting and/or destruction of tissue positionedbetween the exterior of the body and the site where the ablationtreatment was conducted, referred to as the treatment site. Suchconventional surgical procedures were slow, costly, high risk, andresulted in a long recovery time.

Cryoablation is a relatively new procedure in which tissue ablation isconducted by freezing diseased, damaged or otherwise unwanted tissue(collectively referred to herein as “target tissue”). Appropriate targettissue may include, for example, cancerous or precancerous lesions,tumors (malignant or benign), fibroses and any other healthy or diseasedtissue for which cryoablation is desired.

Cryoablation may be performed by using a system that sprays low pressurecryogen on the target tissue. Such systems are often referred to ascryospray systems, cryosurgery spray systems, cryosurgery systems,cryogen spray ablation systems or simply cryospray ablation systems. Asused typically, cryogen refers to any fluid (e.g., gas, liquefied gas orother fluid known to one of ordinary skill in the art) that has asufficiently low boiling point to allow for therapeutically effectivecryotherapy and is otherwise suitable for cryogenic surgical procedures.For example, acceptable fluids may have a boiling point belowapproximately negative (−) 150° C. The cryogen may be nitrogen, as it isreadily available. Other fluids such as argon and air may also be used.Additionally, liquid helium, liquid oxygen, liquid nitrous oxide andother cryogens can also be used.

During operation of a cryosurgery system, a clinician, physician,surgeon, technician, or other operator (collectively referred to as“operator” herein), sprays cryogen on the target tissue via a deliverycatheter. The spray of cryogen causes the target tissue to freeze or“cyrofrost.” This freezing of the tissue often causes the target tissueto acquire a white color (indicative of cryofrost). The white colorindicates that the target tissue freezing has inititated. The physicianmay visually monitor and/or time additional cryospray duration in orderto control the depth of injury. The temperature range for cryofrost canbe approximately negative (−) 10° C. to approximately negative (−) 75°C. Alternatively, the temperature range can be from negative (−) 50° C.to (−) 195° C., particularly in the case of liquid nitrogen at lowpressure. However, the particular temperature for cryofrost will dependon the target tissue, including size, location, etc. The time period toreach cryofrost may vary, from approximately 5 seconds to approximately2 minutes or more depending on the size and location of the targettissue and the thermodynamic potential of the cryogen. A cryosurgerysystem may include a camera system that enables the operator to monitorthe cryogen delivery and determine when cyrofost has occurred.

SUMMARY OF THE INVENTION

According to one aspect of the present invention, there is provided anadvanced cryosurgery system having improved cryogen flow and flowcontrol, an integrated suction pump, a pressure sensor and an improveddelivery catheter.

Embodiments of the present invention are directed to a cryospray systemhaving a cryogen delivery apparatus. In accordance with embodiments ofthe present invention, the cryospray ablation system may further includea cryogen source configured to provide the cryogen to the cryogendelivery apparatus, a regulation apparatus fluidically coupled to thecryogen source and to the cryogen delivery apparatus, and a controllercommunicatively coupled to the regulation apparatus configured tocontrol the release of cryogen into the cryogen delivery apparatus.Exemplary cryosurgery systems in which the present invention may beimplemented include, but are not limited to, those systems described incommonly owned U.S. Pat. Nos. 7,255,693, 7,025,762, 6,383,181, and6,027,499 and U.S. patent application Ser. Nos. 11/956,890 and12/022,013, the entirety of which are each hereby incorporated byreference herein. Embodiments of the present invention are describedbelow in connection with one embodiment of such exemplary cryosurgerysystem shown in FIG. 1.

The system of the present invention is a cryosurgical tool that appliesa medical-grade liquid nitrogen spray to the treatment area via a small,low pressure, open tipped catheter. The system of the present inventionmay optionally include one or more of (1) a console, including a touchpanel computer, a cryogen module, a suction module and an electronicsmodule, all packaged in a mobile cart, and (2) a disposable spray kit.

According to one embodiment, users interact with the console through adual foot pedal and the touch panel. A processor/controller andassociated software manage the cryogen level sensing, filling, pressure,cooling, defrost, suction, timing and/or data management functions. Awireless remote control may provide alternative timer control from adistance in the treatment room. A fill kit, stored on the rear of theconsole, in conjunction with software controls, may allow forsemi-automatic liquid nitrogen transfer from the source tank to theconsole. Safety features may include sensors, indicators, tank pressurerelief valves, an isolated low voltage power system, and an emergencybutton to be used in the event of user or technical malfunction. Thesystem may optionally be mounted on or in a mechanical cart for easymaneuvering. The mechanical cart may have on-board storage built intothe panels for the foot pedals, instructional material (e.g. operatormanual), disposables (e.g., spray kits), remote control and fill kit.Modular design of the console may allow for easy manufacturability andserviceability.

According to another embodiment, users may optionally interact with aactuator button or trigger in the catheter body that allows for engagingadditional control valves or orifices which allow for flow of thecryogen spray onto the treatment site.

According to another embodiment, a spray kit of the present inventionmay include a sterile, single-use flexible catheter a cryogendecompression tube, and pre-cut accessory suction tubes. The catheter isflexible and capable of retroflex in a scope. The cryogen decompressiontube and other accessory tubes are included for use with the on-boardsuction system.

In particular, several key features may be added for optimal cryogenflow/delivery and gas venting:

-   -   optional low cryogen flow setting to reduce the cryogen flow        rate by 50%,    -   cryogen flow consistency that helps reduce pressure pulses and        peaks (through sensors, control systems, and control        algorithms),    -   an integrated suction pump for improved consistency and        self-checks,    -   specified vent tube areas and corresponding maximum expected        pressures during cryospray procedure;    -   optional pressure sensing capability to monitor body cavity        pressure during a treatment, and    -   catheter designed to be retroflex capable.

As a result of the novel cryogen delivery features, the cryogen flowdelivers a consistent flow with minimal pressure pulsing to create anefficient cryogen flow which generates low pressure in the body. As aresult of the gas venting features, the active suction deliversconsistent venting and has settings and warnings that provide greaterflexibility to the physician. The addition of passive ventinginstructions provides information regarding cryogen flow and vent areaso that the physician can make an informed decision on the appropriatecombinations to limit pressure build-up within a body cavity. Inaddition, an optional pressure sensing capability is available tomonitor pressure during a treatment.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present invention will be described in conjunctionwith the accompanying drawings, in which:

FIG. 1 is a perspective view of a cryosurgery system according to anembodiment of the invention;

FIG. 2 is a perspective view of another embodiment of a cryosurgerysystem according to an embodiment of the invention;

FIG. 3 is a perspective view of the interior of an embodiment of acryosurgery system according to an embodiment of the invention;

FIG. 4 is a perspective cutaway view of the reverse side of theembodiment of a cryosurgery system shown in FIG. 3;

FIG. 5 is a schematic showing a cryogen storage, delivery and pressurecontrol apparatus according to an embodiment of the invention;

FIG. 6 is a perspective view of a crysurgery delivery system accordingto an embodiment of the invention;

FIG. 7 is a diagram of venting tube area;

FIG. 8 shows round vent area calculation and maximum expected pressureduring 20 sec cryosurgery.

FIG. 9 shows annular vent area calculation.

FIG. 10 shows annular vent area maximum expected pressure during 20 sec.cryosurgery.

FIG. 11 shows schematic diagram of cryogen flow path and fluidic tuningand control to achieve consistent and stable flow and cooling.

FIG. 12 shows typical pressure response of a “damped” cryogen systemwith ‘critical damping’ indicating minimal overshoot and low peak bodycavity pressure versus an “undamped” system.

FIG. 13 shows front view of a vent tube according to one embodiment ofthe invention.

FIG. 14 is a perspective side view of the vent tube shown in FIG. 13.

FIG. 15 is a perspective view of the vent tube shown in FIGS. 13 and 14,mated with a scope.

FIG. 16 is a front view of a vent tube according to another embodimentof the invention, together with the front face of a scope with which itis mated.

FIG. 17 is a perspective view of the vent tube and scope shown in FIG.16.

FIG. 18 is a side view of an embodiment of a catheter tip according tothe invention.

FIG. 19 is an illustration of an embodiment of the invention in whichthe catheter tip is fitted with a nozzle.

FIG. 20 shows a cryogen recirculating catheter according to anembodiment of the invention.

FIG. 21 is a closeup of the distal tip of the catheter shown in FIG. 20.

FIG. 22 is a sideview of a dual lumen vent tube according to anembodiment of the invention.

FIG. 23 shows an internal cross-section of a diffuser element accordingto the invention.

FIG. 24 shows an external side view of a diffuser element according tothe invention

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

A simplified perspective view of an exemplary cryosurgery system inwhich embodiments of the present invention may be implemented isillustrated in FIGS. 1-3. Cryosurgery system 100 comprises a pressurizedcryogen storage tank 126 to store cryogen under pressure. In thefollowing description, the cryogen stored in tank 126 is liquid nitrogenalthough cryogen may be other materials as described in detail below.The pressure for the liquefied gas in the tank may range from 5 psi to50 psi. According to a more preferred embodiment, pressuring in the tankduring storage is 40 psi or less, and pressure in the tank duringoperation is 35 psi or less. According to a more preferred embodiment,pressure in the tank during storage is 35 psi or less and pressuringduring operation is 25 psi or less. According to a most preferredembodiment, pressure during operation at normal nitrogen flow is 22±2psi, and pressure during operation at low nitrogen flow is 14±2 psi.When the pressure in the tank during operation is set to 22 psi, theflow rate/cooling capacity of the nitrogen is 25 W. When the pressure inthe tank during operation is set to 14 psi, the flow rate/coolingcapacity of the nitrogen is 12.5 W. In an alternate embodiment, thecryogen pressure may be controlled all the way to 45 PSI and to deliverthrough smaller lumen catheters and additional feature sets. In suchalterate embodiments the pressure in the tank during storage may be 55psi or less. For the purpose of this application, the term low pressuremeans 2 psi to 18 psi, preferably 6 psi to 15 psi.

Level and Fill

Liquid nitrogen (LN2) resides on the bottom of the tank and liquidnitrogen gas/vapor (GN2) occupies the top portion of the tank. The tankis supported at three points, 160 a, 160 b, 160 c; see FIGS. 3 and 4.The tank level is measured with a precision load cell 162 under a flangebuilt into the front mount of the cryogen tank and acting of one of thethree support points. The load cell effectively measures a portion ofthe tank's weight, which increases linearly with nitrogen content.Typically, the load cell senses the ⅓ of the weight of the tank. Asignal conditioner amplifies the signal for input to an analog inputchannel of the controller, which is read by the software and used todetermine/display the actual tank level. This system provides improvedlevel of precision for monitoring the tank level than conventional tankweight monitoring systems that rely on spring load systems. In analternate embodiment, tank level is monitored electronically via asensor internal to the tank that changes value with the level of theliquid inside the tank. This can be done in a variety of ways, includingbut not limited to capacitively (an example being a Rotarex C-Stic),resistively, or by measuring differential pressure.

The console of the present invention comes with an insulated quickrelease custom fill hose 164 to fill the tank through the external fillport 166 in a semi-automatic cryogen fill process. A fill port switch168 on the console actuates only when the fill hose is in the lockedposition. During the fill process, liquid nitrogen passes through afilter 170 and transfer valve 172 en route to the tank; see FIG. 5. Thesoftware automatically shuts off the electronic transfer valve 172 whenthe tank is full and vents the hose prior to removing from the console.According to an alternate embodiment, manual filling can take place bymechanically bypassing the electronic transfer and vent valves withmanual valves, thus allowing the tank to be filled without the need forcomputer control.

Pressure

The system of the present invention utilizes valves and a pressuretransducer to continuously monitor and control the pressure of liquidnitrogen in the tank during use. The console monitors the currentpressure of the tank via a pressure transducer 174. The software readsthe current pressure from the transducer and adjusts the pressureaccordingly. If pressure is too low, the software actuates the pressurebuild circuit valve 176 to increase the pressure to a specifiedthreshold and then turns off. When the pressure is too high, thesoftware turns on the vent valve 178 until the pressure reaches aspecified threshold. According to one embodiment, the system allows twouser selectable pressure levels (corresponding to two nitrogen flowrates), normal (24±2 psi/25 W) and low (12±2 psi/12.5 W). According toother embodiments, the system may have selectable pressure levels of22±2 psi/25 W) and low (14±2 psi/12.5 W). Other embodiments may haveranges of normal pressure from 20 to 30 psi (16 to 30 W) and 30 to 55psi. The console of the present invention may have a redundant pressureswitch 180 designed to confirm and ensure accurate tank pressurereadings. According to alternate embodiments, the system of theinvention may have a selectable low pressure level from one quarter tothree quarters of the normal pressure setting. In an alternateembodiment the flow is not achieved via a pressure setting, but insteadvia a feature in the catheter that controls the output flow and pressureat its distal end by the use of a nozzle or length of catheter thatadjusts the flow utilizing the Pouiselle effect relating to the radiusof the pipe that fluid is flowing through. Such embodiment then mayutilize the RFID tag in the console to help identify, set up and reportflow rates, fluid amount monitoring, and catheter type and type of flow(such as low) been given by such accessory.

A mechanical relief valve 182 on the console tank ensures that the tankpressure stays in a safe pressure range. Constant pressure monitoringand adjustment, allows the set point on the mechanical relief valve tobe set at 35 psi, allowing for a low tank storage pressure. A redundantburst disk 184 provides protection should the mechanical relief valvefail. For optimal safety, both electronic and mechanical pressure valvesare present to regulate the pressure, providing triple redundancy in theevent of failure. In addition, a redundant pressure switch was designedinto the system to provide accurate tank pressure readings and ischecked during the built-in-test (BIT). In an alternate embodiment, themechanical relief valve may be set at 60 psi, but still allowing toremain a low pressure storage tank.

Thermal Cooling

The system of the present invention utilizes a manifold assemblycomprised of a cryogen valve 186, catheter valve 188, and defrost valve190 to control liquid nitrogen delivered through the catheter. When thecryogen valve 186 is actuated, liquid nitrogen exits the tank throughthe lance 194 and proceeds through the manifold assembly 196 where anorifice is present to allow cold expanded gas and liquid cryogen to exitthe line through a vent 192 or other fixed orifice and cool down theinternal cryogen circuit. During this precool, the catheter valve 188downstream of the manifold remains closed. A data acquisition boardcollects data from a thermocouple located on the manifold body. In theprecool function, the system software monitors data from thethermocouple, and opens the cryogen valve to cool the manifold when itstemperature is above the desired set-point. In an alternate embodiment,when the cryogen valve 186 is actuated, liquid nitrogen exits the tankthrough the lance 194 and proceeds through the manifold assembly 196where an in-line orifice is present to allow cold expanded gas andliquid cryogen to exit, which will in turn allow for gas to travelthrough a length of pipe or coil that will aid in the warming and totalexpansion of the such gas-liquid mix. This action of allowing thecryogen to escape through the inline orifice precools the pipeline allthe way to the gas expansion junction. A thermocouple mounted at thatjunction monitors to the desired temperature and acts as one of thecontrol variables. In an alternate embodiment, the cold expandedgas-liquid cryogen mix flows through other parts of the cooling circuitto precool additional components before exiting the system. In yetanother embodiment, the cold expanded gas-liquid cryogen mix iscollected in an insulated collection vessel rather than exiting thesystem. Pressure in the collection vessel is monitored and controlled ina way similar to that of the main cryogen tank. Pressure in thecollection vessel is preferably maintained at a pressure lower than thatat the exit point of the venting in-line orifice. Periodically, thecontrolling system will transfer collected cryogen from the collectionvessel back to the primary cryogen tank by pressurizing the collectionvessel to a pressure higher than that of the primary cryogen tank. Thisaction may also include venting the primary cryogen tank to reducepressure, thereby increasing the pressure differential. Once asufficient pressure differential is achieved, the transfer valve is thenopened allowing cryogen to flow from the collection vessel back into theprimary cryogen tank. Upon completion of transfer, the controllingsystem closes the transfer valve and returns pressures back to theirrespective operating levels. The collection vessel may be a separatestandalone tank, or integrated into the primary cryogen tank.

Depressing the cryogen foot pedal 110 opens both the cryogen valve 186and catheter valve 188 allowing liquid nitrogen to flow into thecatheter 128; releasing the pedal stops the flow of cryogen (momentaryaction). The software set-up screen provides two user selectable coolinglevels of cryogen flow, normal and low, described above. Nominal coolingperformance at normal and low flow is 25 W and 12 W, respectively. In analternate embodiment as the two phase flow travels past the cathetervalve 188, it may encounter a second manifold or pipe section with anorifice to allow for expanded gas to vent and divert it away from thecatheter input. In yet another embodiment the two phase flow mayencounter a junction assembly that acts as gas separator by allowing anygas expansion to exit via an in-line orifice in the pipeline which willin turn allow for gas to travel through a length of pipe or coil thatwill aid in the warming and total expansion of the such vented gas. Thevented gas is then allowed to vent to atmosphere safely. In theembodiment, the inline orifice may be made of stainless, or brass. In analternate embodiment, this orifice is made of ruby, sapphire orcorundum. The use of this material allows for precise control of theorifice size as well as for the use of very small hole sizes such as0.020″, 0.038″, or within a range of sizes from 0.010″ to 0.075″.

Low cryogen flow generates considerably less pressure rise with the sameventing area and allows treatment with more precise control. Theprecooling process has been automated on the console of the presentinvention where the prior art console requires the physician to manuallyspray prior to inserting into the scope. Automated precool with internalcirculation (improved over manual flow through catheter) allows improvedease of use and maximizes cooling consistency and minimizes gasdischarged into patient.

In the embodiment illustrated in FIG. 1, a conventional therapeuticendoscope 134 is used to deliver the nitrogen gas to target tissuewithin the patient. Endoscope 134 may be of any size, although a smallerdiagnostic endoscope is preferably used from the standpoint of patientcomfort. In certain embodiments, a specially designed endoscope having acamera integrated therein may also be used. As is known, an imagereceived at the lens on the distal end of the camera integrated intoendoscope 134 may be transferred via fiber optics to a monitoring camerawhich sends video signals via a cable to the a conventional monitor ormicroscope, where the procedure can be visualized. By virtue of thisvisualization, the surgeon is able to perform the cryosurgery attreatment site 154.

As the liquid nitrogen travels from tank 126 to the proximal end ofcryogen delivery catheter 128, the liquid is warmed and starts to boil,resulting in cool gas emerging from the distal end or tip of catheter128. The amount of boiling in catheter 128 depends on the mass andthermal capacity of catheter 128. Since catheter 128 is of smalldiameter and mass, the amount of boiling is not great. (The catheterwould preferably be of size seven French.) When the liquid nitrogenundergoes phase change from liquid to gaseous nitrogen, additionalpressure is created throughout the length of catheter 128. This isespecially true at the solenoid/catheter junction, where the diameter ofthe supply tube to the lumen of catheter 128 decreases fromapproximately 0.25 inches to approximately 0.070 inches, respectively.But the catheter range diameter of its lumen may be between 0.030 to0.100 inches. In an alternate embodiment the gas boiling inside thecatheter may be reduced even greater by the use of insulating materialssuch as PTFE, FEP, Pebax and others to help reduce its temperaturecoefficient. The addition of PTFE is especially desirable if done in theinner lumen because its lower coefficient of friction aids in laminarflow of the fluid and thus reducing turbulence and entropy. This reducesgas expansion and allows for good fluid velocity.

When the liquid nitrogen reaches the distal end of catheter 128 it issprayed out of cryogen delivery catheter 128 onto the target tissue. Itshould be appreciated that certain embodiments the cryosurgery systemmay be able to sufficiently freeze the target tissue without actualliquid nitrogen being sprayed from catheter 128. In particular, a sprayof liquid may not be needed if cold nitrogen gas is capable of freezingthe target tissue. When the catheter sprays out of the catheter distaltip it is described as straight spray. In the alternate embodimentillustrated in FIG. 24 the liquid nitrogen may be broken down into smalldroplets via a diffuser 295 or filter to allow for a very even spraypattern and avoid cold spots of spray pattern. The diffuser 295 may beconstructed of filter paper, a grating patterned polymer, a metal orplastic mesh basket or laser cutting methods on the shaft itself topattern it with very small holes. In such embodiment, the catheter endsin a cap 296 that contains small longitudinal cuts 297 that provide forcontrolled spray to exit as it initially hits a bounce plate 298 on FIG.23. The bounce plate 298 is of a conical shape and helps distribute thespray evenly all around the diffuser 295 and cap 296

Freezing of the target tissue is apparent to the physician by theacquisition of a white color, referred to as cryofrost, by the targettissue. The white color, resulting from surface frost, indicates theonset of mucosal or other tissue freezing sufficient to initiatedestruction of the diseased or abnormal tissue. The operator may use thesystem timer to freeze for a specified duration once initial cryofrostis achieved in order to control the depth of injury. In one embodiment,the composition of catheter 128 or the degree of insulating capacitythereof will be selected so as to allow the freezing of the tissue to beslow enough to allow the physician to observe the degree of freezing andto stop the spray as soon as the surface achieves the desired whitenessof color. The operator may monitor the target tissue to determine whencryofrost has occurred via the camera integrated into endoscope 134. Theoperator manipulates cryogen catheter 128 to freeze the target tissue.Once the operation is complete, cryodecompression tube 132, catheter128, and endoscope 134 are withdrawn.

Proper design and matching of cryogen storage and control componentsallows for stable and well-controlled cryogen flow. The dynamic behaviorof the system can be simply visualized by the lumped parameter model ofFIG. 11, where P represents the pressure in the tank; R_(p) represents“parallel resistance” which models the resistance of the vent orifice192; C represents the fluid compliance capacity (i.e., thecompressibility or “springiness” of the liquid and gas in the tank 126,together with the tank level head height); R_(s) represents the seriesresistance, or the length and inside diameter of the catheter; and Irepresents Inductance, or the weight of the long narrow fluid column inthe catheter. The inventors have discovered a critical intersection ofthese values that provides an ideal and critically damped response tothe cryogen and subsequent gas flow/pressure allowing dramaticallyimproved smoothness and consistency of cryogen delivery to the targettissue as compared to the prior art, as shown in FIG. 12.

Catheter length may be anywhere from 10 inches to 100 inches. Insidediameter of the catheter may be anywhere from 0.8 mm to 5 mm, preferablyfrom 1 mm to 4 mm. The tank size may be anywhere from 5 L to 100 L; itsdiameter may range from 4 inches to 36 inches. The vent orifice of themanifold may be 0.01 inches to 0.1 inches. The inventors have discoveredthat the following critical combination of dimensions provides asurprisingly improved smoothness and consistency of cryogen delivery:catheter length: 84 inches; catheter inside diameter: 0.07 inches; tanksize: 17 L; tank diameter: 12 inches; manifold vent orifice: 0.05inches. In an alternate construction the catheter length may be 75inches with a catheter inside diameter of 0.055 inches; tank size of 28L; tank diameter: 14 inches; cryogen valve gas junction vent orifice of0.038 inches and catheter valve gas junction vent orifice of 0.020inches.

Active feedback control via pressure, resistance or bypass control andalso be incorporated to aid in ideal tuning and response.

Thermal Defrost

The defrost function is useful for thawing the catheter after cryogenspray, before removal from the scope. A defrost circuit directs gaseousnitrogen from the top of the tank through a heater 191 and defrost valve190 to the catheter 128. When the defrost button on the software screenis pressed, the defrost circuit is activated for a prescribed time (e.g.30 seconds) but can be stopped earlier at the user's discretion. A lowvoltage (24 VDC) DC defrost heater delivers 6 W minimum ofwarming/defrost performance but minimizes variation due to line voltageand limits maximum gas temperature, as compared to the prior art linevoltage (120V) AC heater.

FIG. 6 is a perspective view of a portion of a cryosurgery system 200having a cryogen delivery apparatus 240. Cryosurgery system 200comprises an endoscope 202 having lumens 210, 212 and 216 therein. Asshown, endoscope 200 may be positioned in the esophagus 222 of patient250. Lumen 212, disposed in endoscope 202, is configured to receive anendoscope camera 242. An image received at the lens of endoscope camera242 may be transferred via fiber optics to a monitoring camera. Themonitoring camera then sends video signals via a cable to a conventionalmonitor or microscope, where the image captured by the lens can bevisualized. As shown in FIG. 6, endoscope camera 242 may be insertedthrough lumen 212 to allow an operator to view the cryosurgeryprocedure. Lumen 210 is configured to have disposed therein a light 244that is configured to illuminate the treatment site.

Lumen 216 is configured to receive cryogen delivery apparatus 240.Cryogen delivery apparatus 240 comprises a retroflex-capable cryogendelivery catheter 204, catheter tip 206, and one or more holes 214.After insertion of the cryogen delivery apparatus into the patient,cryogen is provided to cryogen delivery catheter 204 from a cryogensource. Tip 206 causes the cryogen to be sprayed on the target tissuevia hole 214. A dual lumen (for both passive and active venting)cryodecompression tube 208 is provided to evacuate the treatment area ofundesirable gases, particles, fluids etc

Treatment site 154 as depicted in FIG. 1 is the esophagus of patient150. It should be appreciated, however, that the treatment site but maybe any location within patient 150 such as inside stomach 152 or othercavities, crevices, vessels, etc. Since freezing is accomplished byboiling liquid nitrogen, large volumes of this gas are generated. Thisgas must be allowed to escape. The local pressure will be higher thanatmospheric pressure since the gas cannot easily flow out of thetreatment site such as the gastrointestinal tract. In the illustratedembodiment, nitrogen gas will tend to enter stomach 152, which has ajunction with the esophagus (the esophageal sphincter) immediatelyadjacent to treatment site 154. In this case, without adequate or quicksuction, stomach 152 of patient 150 may become distended and becomeuncomfortable for patient 150. This buildup of gas could alsopotentially cause stomach 152 or its lining to become damaged or torn.As such, to prevent this buildup of gas in stomach 152, a suction tube132 (e.g., a nasogastric tube) as described hereinafter may be insertedinto the patient to evacuate cryogen and other gases, particles,liquids, etc. from the patient.

Passive Venting

Passive venting is a method in which gas disperses from the treatmentarea by flow through either a natural or artificial orifice/lumenwithout suction. The instructions for use provide physicians withinformation on passive venting (cryogen flow, vent area, vent shape, seeFIGS. 3-6) to limit pressure build-up in the body cavity. The areathrough which gas vents passively must be adequate to ensure excessivedistention does not occur (e.g. 20 mm² at normal flow and 10 mm² at lowflow). An optional (auxiliary) pressure sensing capability is built-into aid the user in monitoring cavity pressure, if desired in either theactive or passive venting modes.

The operating instructions allow physicians to determine the appropriatecryogen flow setting, vent area and vent shape (round, annular) toutilize passive venting. In addition, the smooth and consistent cryogenspray allows for the reduction of pressure/pulsing by 50% at normal flowsettings on the system of the present invention as compared to the priorart. With the low cryogen flow setting, the pressure is significantlyreduced even further. Additionally, the console of the present inventionhas a pressure sense capability that can be used in conjunction withpassive venting that allows the physicians to monitor cavity pressureduring treatment.

Alternatively, the controlled pressure and pulsing, coupled with carefulcontrol of catheter diameter and length helps further deliver controlledflow of volume over time that is consistent with the cryogenic propertyof the fluid being delivered. Dual phase fluid flow is achieved out ofthe catheter distal tip and maintained constantly via the equilibriumthat the system achieves after pre-cool and after the catheter achievesa cold temperature. The range of dual phase fluid cryogen delivery outof a cryogen catheter with this system can range from 5 LPM to 50 LPM(once it all expands into gas). The diameter of the area through whichgas vents passively must be adequate to ensure distention does notoccur. Passive venting may be used with a vent tube when sprayingproximal to a resistor where the lumen is patent (open), or when thetreatment area is open to atmospheric pressure (e.g., dermatological oropen surgery). A lumen sizing device (e.g. stent sizer) may be used tomeasure the lumen to aid in selection of vent tube size. The greater thevent area, the lower the pressure. The vent tube can be a separate tubeused strictly for venting gas and creates a round vent area. The venttube can also provide an annular vent area where the scope passesthrough the center of the tube. FIG. 3 shows a comparison of annular andround vent area. FIGS. 4 and 5 show vent areas (mm²) for different scopesizes and vent tube inner diameters (ID). The distal end of the passiveventing tube should be placed in an unobstructed cavity near theprocedure area if area is not sufficiently open to atmospheric pressure.If used, the proximal end of the passive venting tube should bepositioned outside the body where the pressure is atmospheric. FIGS. 4and 6 show maximum expected pressures during a 20-second spray usinground or annular vent shape, respectively. In FIG. 17 the vent tube 260takes the shape of sleeve with a lumen 261. Such sleeve 262 or groovedchannel 262 can then be utilized to slip the scope 263 into it to allowfor the scope insertion into the body cavity to be the placementmechanism. The vent tube is flexible enough that the functionality ofthe scope is not hindered. The tube ends with an open end 264 to vent tothe atmosphere. FIGS. 13 and 14 show another version of the vent tube266 with the sleeve rolled up 265 upon unpackaging, and a scope locationopening 267, and a vent orifice 268. As shown in FIG. 15; it is unrolledover the scope shaft 269. And ready for use. FIG. 15 also shows thecryospray catheter 270 located out of the scope working channel. Thevent hole may be of dual vent lumen or single vent lumen constructionwhich in turn supports both passive and active (suction) venting.

Active Venting (Suction)

Active venting (suction) is the venting method in which the onboardsuction is used to evacuate gas from the treatment area via the cryogendecompression tube 132. The suction is controlled by the physicianthrough the use of a dual foot pedal (cryogen/suction) 101. Pressing thesuction foot pedal 111 activates suction; pressing the suction footpedal again de-activates suction (toggle action).

The on-board suction module is preferably mounted inside the lower frontpanel of the console. The suction control panel consists of a pump 168,control module, valve and sensor. The software set-up screen providestwo user selectable levels of suction (normal, low). The front enclosureprovides space for attaching a suction canister 169 and accessory tubing167 One piece of pre-cut accessory tubing connects the suction canisterto the console pump; another piece of pre-cut accessory tubing connectsthe suction canister to the decompression tubing. Electronic controlswithin the console verify adequate vacuum and allow the physician tocontrol application of suction through the cryogen decompression tubeusing the foot pedal.

The prior art required the use of an external suction pump, while theconsole of the present invention has an integrated suction pump toimprove overall consistency and provide control and self-checks. Thepresent invention uses a normal vacuum setting to evacuate liquids thatmay accumulate in the treatment area or cryogen decompression tube inaddition to removing the cryogen gas. The console of the presentinvention also has an additional, lower vacuum setting (50%) to allowthe physician to pull less suction in certain situations (e.g., whereflaccid lumen inhibits vision or movement). The integrated suction pumpand sensor (32 lpm) improves consistency, suction flow, suctionflexibility robustness relative to prior art external suction pump andgauge (25 lpm).

Spray Kit

The spray kit consists of a carton of five (5) sterile, single-usecatheters with introducers in individual pouches and a carton of five(5) sterile, single-use CDTs with associated tubing in individualpouches. Each carton within a spray kit contains the instructions foruse.

Catheter

The catheter is designed to transport liquid nitrogen from the consoleto the patient treatment site. The catheter contains (1) a bayonet andhub for attachment to the console at its proximal end, (2) a layeredpolyimide and stainless steel braided shaft to minimize kinking andbreaking, (3) insulation to protect the user from cold, (4) a strainrelief to help prevent kinking when torqued by users and (5) anatraumatic tip at its distal end to prevent damage to tissue. Thelaminated construction and braided material provides additional strengthand flexibility, allowing the physician to retroflex the catheter duringa treatment procedure, if needed. The catheter pouch contains an RFIDtag that the user scans prior to use to prevent reuse and trackdisposable information. The catheter pouch also contains an introducerthat provides reinforcement for the catheter and helps prevent kinkingduring use and when placing the catheter into the scope. The catheter ispackaged in a protective tube to prevent damage during shipping.

The delivery catheter is comprised of three layers of flexiblepolyimide, surrounded by a stainless steel braid, which is in turncoated with an outer later of Pebax. It was discovered that thatextrusion of Pebax over the stainless steel braid allows the Pebax towick through the pitch of the steel braid, helping to prevent kinking,breaking, or delamination during retroflex of the catheter. The Pebaxalso provides a desirable balance between hardness—important for smoothsliding of the catheter and general toughness, and softness, which isimportant for some degree of tackiness which allows the user to feel themovement of the catheter in the scope. The pitch of the stainless steelbraid is configured to be fine enough to afford the required strength,not thick enough to allow the Pebax to wick through. The distal end ofthe catheter is provided with an atraumatic tip comprised only of Pebax,in the shape of a bullnose. This novel constructions allows forretroflex of the catheter without kinking, breaking, or delamination ofthe catheter. For the purposes of this invention, retroflex is used torefer to the ability of a catheter to bend or turn approximately 180°about a radius of curvature of 1 inch or less. This is useful so thatwhen the catheter is introduced into, for example, the stomach via theesophagus, the catheter can be turned approximately 180° in order totreat the roof of the stomach.

In alternate embodiments the distal end of the catheter may be apreformed plastic tip (typically Pebax) with a specific geometry thatallows for specific spray patterns other than those coming out of thecatheter shaft end (aka. straight spray). FIG. 18 demonstrates acatheter 271 with a spray pattern tip 272 that shows holes 273, 274, 275of different sizes at different distance positions that allow forgradual spray across a specific distance of the catheter shaft 271. Thehole patterns 273, 274, 275 may have dimensions that are between 0.015″to 0.050″ in diameter. In this illustration, the hole at the distal endof the catheter 276 for straight spray may or may not be there and it isof a diameter that is also different from the rest. This diameter ofthis hole 276 may have a range or 0.020″ to 0.085 inches. Theconstruction of this tip may be achieved via drilling of the differenthole sizes, fusing or adhering a preformed and predrilled tip or insertmolded via micromolding techniques.

In yet another alternate embodiment, the control of the cryospray isachieved through a nozzle flow created by shafts of a certain length anddiameter size. FIG. 19 demonstrates how the Pressure of the console 277may remain constant, but the combination of catheter shaft 278 andnozzle 279 are used to throttle the output flow at the distal end of thecatheter 280 with a specific output flow. The nozzle 279 length can havea range of 0.050″ to 48 inches in length and an inner diameter of 0.030to 0.080 inches. Likewise the catheter shaft 278 of this constructioncan have a range of 1.5 inches to 90 inches when coupled with the nozzleconstruction. The catheter shaft can have an inner diameter range of0.30 to 0.125 inches.

Another embodiment to be mentioned contains a catheter with atemperature probe attached to the distal end of the catheter. This isachieved by laying at least two wires longitudinally or in a coilpattern prior to the outer layer of polymer laminated onto the catheterouter layer. If the wires are thermocouple wires, then they can beterminated into a thermocouple. Alternatively, a cryogenic thermistorcan be attached to the distal end of the catheter. Such thermistor canthen be encapsulated via conductive epoxy and an FEP heat shrink tosleeve it. Then the thermistor can be used to monitor both thetemperature at the end of the catheter tip as well as the treatment areafor both freezing and thawing temperature monitoring.

One more alternative embodiment that we wish to discuss is the inventionof a dual lumen of lumen within lumen catheter construction. Suchconstruction results in a cryospray catheter that can now be precooledvia the recirculation of fluid all the way to its distal end. FIG. 20describes such method. The precooling is either achieved by the consolecontrol or the user's input command (like via a foot pedal). Thecryospray catheter 281 contains a valve or shutter 282 that is thenengaged either via the console control or the user. FIG. 20 describesthe trigger type mechanism 283 that is engaged by the user for theduration of the spray to the treatment site. The mechanism 283 can bespring loaded to allow it to retrieve to the close position aftertreatment time is done. The valve is mechanically connected remotely tothe trigger mechanism 283 via an engagement wire 284 running along thelength of the catheter shaft 285. The wire 284 is connected to a sleevesliding sleeve so that when the trigger is engaged the sleeve slidesback and opens up the elastomeric diaphragm as shown retracted in dashedlines. A failsafe to the valve 282 opening and closing is the user candepress the console flow control that stops the recirculation along thecatheter shaft 285 if the mechanical trigger fails to immediatelyretract due to freezing issues. The catheter shaft consists of duallumens with an input and an output port for the path of recirculation.

In FIG. 21, the recirculation path is shown via an inner lumen 288 thatis surrounded by an outer lumen 289 which returns the dual phase fluidflow back to the console for recollection. Holes on the inner lumen 288allow for this to occur.

Cryogen Decompression Tube

The cryogen decompression tube 132 aids evacuation of nitrogen gas fromthe treatment site. The cryogen decompression tube connects via suppliedaccessory connection tubing 167 to a disposable suction canister 169 onthe front of the console. The dual lumen cryogen decompression tube arecoupled by ports that provide both active (to the suction pump) andpassive (direct to ambient) vent paths.

The dual lumen cryodecompression tube may be of the form on FIG. 22,where each lumen is independently vented to either a suction pump tubeconnection or a passive open air connection 291. The passive venting mayserve the function of vent during cryospray, but also the function ofworking channel to supplement the absence of a working channel if thecatheter is inserted into the working channel of the scope. Such workingchannel can be used for tissue manipulation, forceps, biopsy, amongother uses.

Scan/RFID

Spray kit usage is tracked by scanning a Radio Frequency Identification(RFID) tag on the catheter packaging. The RFID reader 306 is mounted onthe right side of the console. When a valid spray kit is detected, theassociated indicators on the set up screen are updated and a three hourtimer is started and constantly visible to the user for monitoring ofprocedure time. In the preferred embodiment the RFID tag is scanned bythe user upon connection of the catheter, and the catheter type loggedon the system. In an alternate embodiment such RFID tag may be locatedon the device itself, instead of the packaging and recognized uponcatheter connection by the user. Such connection may identify cathetertype, spray flow output, and provide the pressure setting value for thesystem to adjust to for treatment.

Control/Electronics Panel

The control panel is located in the top upper section of the console andincludes the following: auxiliary panel (pressure port 308, thermocoupleinput port 310 and digital input ports 312), emergency stop 314, USBport, catheter interface 318 and transfer interface, including externalfill port 166. The catheter port on the console of the present inventionhas spring-loaded capture pins for good connection and good tacticalfeel on insert and removal.

The electronics panel houses the compact data acquisition (cDAQ)controller, the level sense signal conditioner, the auxiliary pressuresensor, the interface board, the heater relay, the power supply and thepower supply filter. The cDAQ controller contains removable DAQ modulesthat measure and output various signals and controls to and from theconsole. All signals and controls in the console are routed through aninterface/interconnect board. The console of the present invention usesa universal medical grade power supply that powers all internaloperations using 24 volts through the interface/interconnect board.Power from the 24 VDC medical grade power supply is distributed to allconsole components through the interface board.

User Interface/Platform

The improved system of the present invention utilizes a graphical userinterface (GUI) deployed on a touch panel. The software is comprised ofsix main application codes that govern operation of the system: Home,Fill, Test, Run (Procedure), Data and Service.

The Home module provides the central menu and access to the fiveapplication modules. Three (3) buttons located in the center of the Homescreen allow access to the three main modules: Fill, Test and Run. Dataand Service buttons are normally hidden; however, pressing the CSA logomakes them visible. Service is password protected allowing onlyauthorized CSA personnel access. The module application codes areaccessed by selecting the applicable button from the Home screen.

The Fill module implements a semi-automatic fill process that (1)verifies the fill hose is connected before proceeding, (2) controlsapplicable valves required for filling the tank, (3) displays the realtime tank level and (4) automatically shuts off when the tank is full.

The console of the present invention includes a semi-automated fillprocess accessed from the front of the console that provides graphicalinformation to monitor the fill process. The prior art is a manualprocess conducted at the rear of the console that does not include avisual display during fill.

The test module implements an automatic built-in test (BIT) whenpowering up the console or when selected by the user. The BIT checkseach hardware module and verifies performance of the system prior toentering the procedure code (i.e., Run button). Upon completion, the BITautomatically returns to the Home module. Once the BIT is completed, theRun button is enabled for entrance into Run Mode. If the BIT fails, astatus indicator on the Home screen alerts the user of the requiredaction and disables the Run button. The console of the present inventionallows the user to view both quantitative and pass/fail results for eachtest as they are completed as well as an overall result.

The procedure application module (Run button) controls the thermal,timing and suction functions and is used during the treatment ofpatients. When the Run button is pressed, the user can select from aset-up screen or a run screen. The set-up screen monitors key systemparameters (scan, tank level, pressure, and thermal) with color codedtext indicators to indicate operating states (green ready, red notready). The set-up screen also contains controls for selecting cryogenflow (normal/low), suction (normal/low), and sound volume (normal/low).The run screen provides inputs to set and control the timer, precool anddefrost. The run screen also provides color coded procedure, suctionstate/warning indicators and auxiliary pressure indicators.

The console of the present invention has optional lower cryogen flow andsuction setting. The system of the present invention displays additionalinformation regarding the system status (e.g., tank level, tankpressure, precool, cryogen state, suction/venting state).

The Data module provides the ability for the user to view and downloadlog files through a drop down menu. There are a total of six (6) logsthat are visible to the user (fill, test, procedure, system, error, andservice) to view relevant details. Log files may be downloaded to a USBdrive for off-line viewing and aid in service support.

The console of the present invention provides the ability for the userto read and display log files directly on the panel PC, improvingserviceability and ease-of-use. The prior art has independent servicesoftware to extract and view the data logs.

Remote Control

Various timer controls found on the main console are duplicated on ahand-held remote control: site increment/decrement, cycleincrement/decrement and timer start/stop and clear. Large blue buttonson a white background provide desired optical contrast and visibility inlow light environments and good tactical feedback. Communication usesthe IEEE 802.15.4 communication standard and chips in both the consoleand remote control contain a unique serial number that is used toestablish a one-to-one connection.

Although the present invention has been fully described in conjunctionwith several embodiments thereof with reference to the accompanyingdrawings, it is to be understood that various changes and modificationsmay be apparent to those skilled in the art. Such changes andmodifications are to be understood as included within the scope of thepresent invention as defined by the appended claims, unless they departtherefrom.

What is claimed is:
 1. A cryosurgical apparatus for cryogenic spraytreatment comprising: a cryogen tank; a cryogen pressure maintenancesystem; a cryogen level monitoring system connected to said cryogen tankfor monitoring a cryogen level in said cryogen tank, said cryogen levelmonitoring system comprising an electronic sensor internal to thecryogen tank that measures tank cryogen level via resistive orcapacitive means, and electronics for communicating the sense value tothe onboard computer system; a cryogen tank fill system connected tosaid cryogen tank and having a port configured to detachably connect toan external cryogen source; a catheter attachment apparatus mounted onsaid cryosurgical apparatus and connected to said cryogen tank via amanifold assembly; a fluid path pre-cool system arranged between saidcryogen tank and said catheter attachment apparatus; user-control systemfor user-control of cryogen spray mounted to said cryosurgical apparatusand in electronic communication with said manifold assembly; a displayscreen mounted on said cryosurgical apparatus; and an on-board controlsystem in electronic communication with said cryogen tank fill system,said manifold assembly, and said fluid path pre-cool system, saidon-board control system comprising a computer readable medium containingcomputer readable instructions for monitoring and controlling cryogentank fill operation, running pre-procedure system checks, controllingfluid path pre-cool, and controlling thermal functions during usertreatment of patients.
 2. The apparatus according to claim 1, furthercomprising a fluid path defrost system connected to said manifoldassembly.
 3. The apparatus according to claim 1, further comprising acryogen pressure monitoring system connected to said cryogen tank andconfigured to monitor pressure in said cryogen tank.
 4. The apparatusaccording to claim 3, wherein said cryogen pressure monitoring systemand said cryogen pressure maintenance system are configured to be activeduring cryospray treatment of a patient, wherein said cryogen pressuremonitoring system comprises an electronic pressure sensor configured tomonitor the pressure of the cryogen tank, wherein said cryogen pressuremaintenance system comprises an electronic pressure build solenoidconfigured to respond to instructions from said on-board control systemto selectively allow flow of liquid cryogen from a lower portion of saidcryogen tank to an upper portion of said cryogen tank in order toincrease the pressure thereof as necessary, and wherein said cryogenpressure maintenance system further comprises an electronic solenoidvent under control of said on-board control system to selectively ventcryogen from said cryogen tank to decrease the pressure thereof asnecessary.
 5. The apparatus according to claim 1, further comprising anon-board suction apparatus mounted on said cryosurgical apparatus. 6.The apparatus according to claim 5, wherein the on-board control systemis in electronic communication with the on-board suction apparatus andwherein the on-board control system is configured to accept a userprovided selection of passive venting only, or active venting at aplurality of discrete suction powers.
 7. The apparatus according toclaim 1, wherein said on-board control system further comprisesapparatus for adjusting cryogen pressure.
 8. The apparatus according toclaim 1, wherein said on-board control system further comprisesapparatus for controlling fluid path defrost.
 9. The apparatus accordingto claim 1, wherein said on-board control system further comprisesapparatus for controlling suction functions.
 10. The apparatus accordingto claim 1, configured to be mobile.
 11. The apparatus according toclaim 1, further comprising a cryogen delivery catheter configured toconnect to said catheter attachment apparatus and deliver low pressurecryogen spray to a treatment area through an endoscope or sheath orsimilar apparatus.
 12. The apparatus according to claim 1, furthercomprising a cryogen decompression tube configured connect to saidon-board suction apparatus and to allow passive venting and/or activeventing with the aid of suction from a treatment area.
 13. The apparatusaccording to claim 12, where a distal end of the decompression tubeterminates in a Y-shaped connection that allows for suction to engage atube cavity, while still allowing the decompression tube to vent intoatmosphere and to serve as supplemental working channel.
 14. Theapparatus according to claim 12, further comprising a cryogendecompression tube configured to allow passive venting and/or activeventing with the aid of suction from a treatment area, wherein saiddecompression tube comprises a sleeve or sheath opening for sliding ascope into said decompression tube for proper insertion and placement.15. The apparatus according to claim 1, wherein said cryogen levelmonitoring system comprises a plurality of support points supportingsaid cryogen tank on said cryosurgery apparatus; and an electronic loadcell located at one or more of said support points configured todetermine the load borne by the support; said electronic load cell inelectronic communication with said onboard control system forcommunicating load values to the onboard control system.
 16. Theapparatus according to claim 1, wherein said cryogen fill systemmonitors a level of cryogen in the cryogen tank level and sendsinstructions to an electronic cryogen fill solenoid to close off flow ofcryogen into said cryogen tank and automatically vents a supply hose.17. The apparatus according to claim 1, wherein the on-board controlsystem is configured to accept a user selection for delivery of cryogenat a plurality of discrete pressures.
 18. The apparatus according toclaim 1, wherein the system is configured to automatically set one ormore cryogen delivery parameters from a plurality of pre-set discretepressures based on a type of catheter connected.
 19. The apparatusaccording to claim 18, wherein such system selection of deliverypressure is determined via a stored value on a memory device of thecatheter connected.
 20. The apparatus according to claim 1, wherein theon-board control system is configured to accept a user providedselection of automatic operation of the fluid path pre-cool system. 21.The apparatus according to claim 1 wherein the on-board control systemis configured to automatically start fluid path pre-cool upon connectionof the cryospray catheter.
 22. The apparatus according to claim 1, wherethe cryogen fluid path precool system comprises an insulated collectionvessel configured to collect gas-liquid cryogen mix and feed it back tothe main cryogen tank.
 23. The apparatus according to claim 1,comprising a cryogen collection apparatus adjacent to a cryogen deliverypath, and an insulated collection vessel mounted in said cryosurgeryapparatus, said cryogen collection apparatus configured to collectcryogen that has leaked or escaped from said cryogen delivery path, saidinsulated collection vessel configured to feed said leaked or escapedcryogen to said cryogen tank for redelivery.